510(k) Report

Devices descending from K082014

837 later devices reach Stryker Spine Avs PL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K141135Juliet LLSpineart2014146—
+3K142277Juliet POSpineart2014119—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K242303MOD-COrthomod, LLC20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—